Ciprofloxacin BioThrax Co-Administration Study

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The purpose of this clinical trial is to determine whether there is any effect on the antibiotic, ciprofloxacin when taken before and after administration of a 3-dose series of BioThrax® (Anthrax Vaccine Adsorbed or AVA).

This study will be conducted in the United States (US) in 154 healthy male and female volunteer subjects ages 18 to 45.

The duration of study participation for each subject will be approximately 76 days (approximately 2.5 months)

Condition or disease

Intervention/treatment

Phase

Anthrax

Biological: BioThraxDrug: Ciprofloxacin

Phase 2

Detailed Description:

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. This is a randomized, open-label, Phase 2, multi-center trial to investigate the potential interactions of ciprofloxacin and BioThrax.

Blood was collected in arms 1 and 2 at day 48 ( 2 weeks following last vaccination) and in arm 3 at day 43 ( 2 weeks following last vaccination) for TNA assay to determine the NF50 antibody titer for calculating GMT.

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Ages Eligible for Study:

18 Years to 45 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Be between 18 and 45 years of age, at the time of enrollment

Be in good health as determined by the investigator from medical history and a physical examination.

If a pre-menopausal female, must be using acceptable methods of birth control.

Be willing and able to return for all follow-up visits and blood and urine collections for the duration of the trial

Be willing and able to complete a web-enabled electronic diary and report concomitant medications, adverse events, and BioThrax reactogenicity events during the trial

Be able to understand and communicate in English.

Exclusion Criteria:

Prior immunization with anthrax vaccine or known exposure to anthrax organisms

Intend to enlist in the military during the study.

Have a known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, or latex.

Plan to receive experimental products 30 days prior to study entry or at any time during the study